ZOSTAVAX is a vaccine. It is a powder and solvent to be made up into a suspension for injection. The active substance is the attenuated (weakened) varicella-zoster virus.

What is ZOSTAVAX used for?

ZOSTAVAX is used to vaccinate people aged 60 years or older, to prevent herpes zoster (also known as zoster or shingles) and the long-lasting nerve pain that may follow the disease (post-herpetic neuralgia). The medicine can only be obtained with a prescription.

How is ZOSTAVAX used?

ZOSTAVAX is provided as two separate components: a powder that must be kept frozen, and a solvent, in a vial or pre-filled syringe, that is kept in a refrigerator or at room temperature. Immediately before administration, the doctor or nurse will need to make up the suspension for injection by dissolving the frozen powder with the solvent. They will then inject the suspension subcutaneously (just under the skin) preferably into the upper arm.

How does ZOSTAVAX work?

Herpes zoster, or shingles, is a disease caused by the varicella-zoster virus, the same virus that causes chickenpox. Shingles develops in people who have had chickenpox earlier in life, generally as a child. After chickenpox, the varicella-zoster virus stays in the body, in the nervous system, in a ‘dormant’ (inactive) state. Sometimes, generally in older people, and for reasons which are not fully understood, the virus becomes active again, and the patient develops shingles, a painful, blistering rash typically in one part of the body. The rash takes usually several weeks to clear, and afterwards, there may also be pain, which can be severe and may be lasting months (post-herpetic neuralgia) in the area where the rash was.

The risk to develop shingles seems to be linked to a decline in the specific immunity (the way the body defends itself) against varicella-zoster virus. ZOSTAVAX is a vaccine that was shown to “boost” this specific immunity, which is thought to be the mechanism by which it protects against shingles and the pain the disease is associated with.

How has ZOSTAVAX been studied?

The main study of ZOSTAVAX compared the medicine to a placebo (a dummy vaccine) in over 38,500 patients aged between 59 and 99 years of age. The study was a double-blind trial, which means that neither the doctor nor the patient knew what treatment the patient was receiving. The patients were followed for 2 to 4.5 years after vaccination. The measure of the effectiveness of ZOSTAVAX was based on the number of people who developed shingles and post-herpetic pain during the study.

What benefit has ZOSTAVAX shown during the studies?

ZOSTAVAX was more effective than placebo in preventing the development of shingles. Less people developed shingles after vaccination with ZOSTAVAX than after receiving a placebo injection: 315 of the 19,254 patients who received the medicine had shingles during the study, against 642 of the 19,247 who received a placebo. This means that vaccinating 1,000 people with ZOSTAVAX will cut the number of cases of shingles seen over one year from about 11 to 6. ZOSTAVAX was also more effective than placebo in its effect on post-herpetic neuralgia: 27 of the ZOSTAVAX patients had post-herpetic neuralgia, against 80 in the placebo group.

What is the risk associated with ZOSTAVAX?

In studies, the most common side effects (seen in more than 1 patient in 10) are reactions at the site of the injection (redness, pain, swelling, itching, warmth and bruising). For the full list of all side effects reported with ZOSTAVAX, see the Package Leaflet.

ZOSTAVAX should not be used in people who may be hypersensitive (allergic) to any of the ingredients of the vaccine , including neomycin (an antibiotic). The vaccine should not be used in people who have problems with their immune system, either because they have a disease such as leukaemia, lymphoma, AIDS, or because they are taking medicines that affect the immune system. It should also not be used in patients with active untreated tuberculosis and in pregnant women. For the full list of restrictions, see the Package Leaflet.

Why has ZOSTAVAX been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that ZOSTAVAX’s benefits are greater than its risks for the prevention of herpes zoster (“zoster” or shingles) and post-herpetic neuralgia in individuals from 60 years of age. They recommended that ZOSTAVAX be given marketing authorisation.

Which measures are being taken to ensure the safe use of ZOSTAVAX?

The company that makes ZOSTAVAX will look at the use of the vaccine in patients whose immune system is weakened. They will also study the duration of the protection that the vaccine gives.

Other information about ZOSTAVAX

The European Commission granted a marketing authorisation valid throughout the European Union for ZOSTAVAX to Sanofi Pasteur MSD SNC on 19 May 2006.

Authorisation details

Name: Zostavax

EMEA Product number: EMEA/H/C/000674

Active substance: varicella-zoster virus (live, attenuated)

INN or common name: zoster vaccine (live)

Therapeutic area: ImmunizationHerpes Zoster

ATC Code: J07BK02

Marketing Authorisation Holder: Sanofi Pasteur MSD, SNC

Revision: 11

Date of issue of Market Authorisation valid throughout the European Union: 19/05/2006